MedPath

GP-101

Generic Name
GP-101

Avalyn's Inhaled Nintedanib Shows Promising Safety Profile in Phase 1 Trials for IPF Treatment

• Avalyn Pharma has successfully completed Phase 1 clinical trials of AP02, an inhaled formulation of nintedanib, demonstrating safety and favorable tolerability at all tested dose levels in healthy volunteers and IPF patients. • The novel inhaled delivery approach aims to maximize therapeutic impact while minimizing systemic exposure, potentially addressing key limitations of current IPF treatments that are associated with significant toxicities. • Based on these positive results, Avalyn plans to advance AP02 into Phase 2 clinical trials for idiopathic pulmonary fibrosis, with full data presentation scheduled for the American Thoracic Society 2025 International Conference in May.

Qureight's AI Imaging Platform to Support Avalyn's Inhaled Pirfenidone Trial in Pulmonary Fibrosis

• Qureight and Avalyn Pharma have formed a strategic partnership to integrate deep-learning imaging technology in the Phase 2b MIST trial evaluating inhaled pirfenidone (AP01) for progressive pulmonary fibrosis. • The collaboration marks the first-ever use of deep-learning imaging technologies in a progressive pulmonary fibrosis clinical study, aiming to enhance treatment response measurement. • Avalyn's inhaled pirfenidone formulation targets improved efficacy and reduced side effects compared to current oral antifibrotic therapies by delivering medication directly to affected lung tissue.
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